On September 10, 2018 ERYTECH Pharma (Euronext: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, reported its financial results for the quarter ended June 30, 2018 (Press release, ERYtech Pharma, SEP 10, 2018, View Source;p=RssLanding&cat=news&id=2366796 [SID1234529397]).
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"In the first half of 2018, we completed our strategic transition towards solid tumor indications of high unmet medical need," said Gil Beyen, Chief Executive Officer at ERYTECH. "Specifically, we are excited that our pivotal Phase 3 trial with eryaspase in second line pancreatic cancer is open for enrollment. In addition, we are launching a Phase 2 trial in a first line triple-negative breast cancer, our second solid tumor indication and patient enrollment is expected to begin in the fourth quarter of this year. With both trials on track, we are expanding our teams and manufacturing capacity in Europe and the United States to support the anticipated clinical demand for product supply. Simultaneously, we are advancing our preclinical programs."
Business Highlights
Following the positive Phase 2b results with its lead product candidate eryaspase in second line metastatic pancreatic cancer and feedback from the U.S. Food and Drug Administration (FDA) and the Commission for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA), ERYTECH has initiated activities on a pivotal Phase 3 trial in the same indication during the first half of this year. The study, named TRYbeCA1, is on track for first patient enrollment before the end of the third quarter. Clinical trial authorizations and ethical committee approvals have been received in different European countries and the first clinical sites have been opened. Start of patient enrolment in the United States is expected early next year. The TRYbeCA1 trial is evaluating eryaspase in combination with standard chemotherapy (gemcitabine/paclitaxel or irinotecan-based regimen) compared to standard chemotherapy alone in approximately 500 patients at 120-130 sites within the United States and Europe. The primary endpoint is overall survival (OS). An interim analysis is foreseen when approximately two-thirds of events have occurred.
In February, the Company selected triple-negative breast cancer (TNBC) as the next solid tumor indication for the development of eryaspase. A Phase 2 proof-of-concept clinical trial, TRYbeCA2, has been designed. The TRYbeCA2 trial will evaluate eryaspase in combination with gemcitabine and carboplatin, compared to chemotherapy alone, in approximately 65 previously untreated patients with metastatic TNBC in Europe and the United States. The primary endpoint will be objective response rate. Set up activities are ongoing and start of patient enrollment is expected around year end.
In order to ensure adequate supply of eryaspase for its planned clinical trials, as well as the anticipated initial commercial needs of eryaspase, if approved in these larger indications, the Company is establishing a manufacturing facility in the United States (Princeton, New Jersey) and is also expanding its manufacturing capacity in Lyon, France.
In May, the Company announced the expansion of its executive management team with the addition of Alex Dusek as VP of Commercial Strategy to lay the groundwork for planned commercial launch and ensure commercial product preparedness, primarily in the United States. He brings over 25 years of experience including commercial strategic roles at Argos Therapeutics, Bayer and United Therapeutics.
In June, the Company announced that it would cease the development of eryaspase in acute lymphoblastic leukemia (ALL) and confirmed its strategic shift to solid tumors. The resources that become available as a result of this decision will be utilized to broaden the development in selected solid tumors where metabolic pathways are activated, including in other settings in pancreatic cancer. ERYTECH believes that the solid tumor indications being pursued represent a significantly larger market opportunity than ALL.
Several preclinical programs, all leveraging the Company’s proprietary ERYCAPS encapsulation platform, are ongoing. The Company’s next product candidate, erymethionase, methionine-gamma-lyase encapsulated in red blood cells, is also targeting solid tumor indications. Erymethionase recently completed non-clinical development and activities in support of initiating a Phase 1 clinical trial are ongoing. ERYMMUNE, the Company’s immuno-oncology program, and ERYZYME, the encapsulation of enzymes used in therapies to treat metabolic diseases, are also progressing.
Financial Highlights
Net loss for the six-month period ended June 30, 2018 was €19.0 million, compared to €14.1 million in the same period of 2017. The €4.9 million increase was primarily attributable to:
An increase in R&D expenses by €4.7 million, mostly related to the Company’s intensified clinical and regulatory activities (€2.9 million), as well as the continued increase (€1.7 million) in preclinical research activities.
An increase in G&A expenses by €3.5 million, reflecting the continued structuring of the company (€2.5 million) and the increased costs associated with becoming a public company in the U.S. (€1.0 million).
The accounting of a €2.9 million financial income, as the Company’s cash position denominated in euros was impacted by the positive currency exchange variation in the period of the U.S. dollar against the euro in the overall period.
As of June 30, 2018, ERYTECH had cash and cash equivalents totaling €165.4 million, compared with €185.5 million as of December 31, 2017. The €20.1 million decrease in total cash and cash equivalents in the six-month period comprised a total net cash utilization of €22.5 million for operating, investing and financing activities, and a €2.4 million favorable foreign exchange impact on the Company’s cash position denominated in U.S. dollars, related to the appreciation of the U.S. dollar against the Euro in the first half of 2018. The company expects an increase in cash utilization in the second half of 2018, associated with the execution of the clinical plan and the related manufacturing capacity investments.
Key Upcoming Milestones
First patient in the pivotal Phase 3 clinical trial in second-line pancreatic cancer in Europe and the United States
First patient in the Phase 2 proof-of-concept clinical trial in TNBC
Completion of CMC activities with erymethionase in preparation of the start of a Phase 1 clinical trial
Second Quarter Results 2018 Conference Call Details
As a reminder, ERYTECH management will hold a conference call and webcast on Tuesday, September 11, 2018 at 02:30pm CET / 08:30am EDT to discuss business highlights and financial results for the second quarter of 2018. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will host a brief presentation, followed by a Q&A session.
The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 4983808#
USA/Canada: +1 (833) 818-6807 France: +33 176748988
International Dial-In Number: +1 (409) 350-3501 United-Kingdom: +44 2031070289
The webcast can be followed live online via the link: View Source
An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 4983808#.
2018 Financial Calendar:
Business Update and Financial Highlights for the third quarter of 2018: November 12, 2018 (after U.S. market close), followed by a conference call and webcast on November 13, 2018 (2:30pm CET/8:30am ET)
Upcoming Investor Conferences:
Morgan Stanley Healthcare Conference, September 13, New York
BoursoCap, September 18, Paris
Midcap Event Paris, October 9, Paris
Jefferies Healthcare Conference, November 14-15, London
Actionaria, November 22-23, Paris